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NCT Number: NCT03786653

Feasibility of Immunotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting (ImHADom)

This observational prospective monosite study aims to describe, for the first time, management in a hospital-at-home programme of patients treated by immunotherapy for bronchial cancer.

The feasibility in good conditions of this management, the patients' quality of life and their satisfaction will be evaluated.

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Key information

Conditions

Bronchial Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre hospitalier de pau

Pau, Aquitaine, 64160, France

About this study

Those last years, immunotherapy treatment for bronchial cancers allowed considerable progress in terms of tumoral answer, survival without progression and global survival. Usually administered in the day hospitalization department, its preparation and administration to the patient are compatible with hospital-at-home management. Currently, this offer of care is rarely proposed, and only in particular situations. At the Hospital of Pau, it was introduced recently. It is proposed to patients who have been receiving immunotherapy for at least 4 months. At the moment, there is no study stating the feasibility of home hospitalization for patients treated by immunotherapy. Given that there is neither regulatory obstacle nor any contraindication to care in home hospitalization, the choice of a descriptive study stands out.

This study will be proposed to all the patients for whom home hospitalization has been decided and scheduled by the healthcare team in a medical staff meeting.

The patients included in the study will be followed according to the common practice: a consultation every 3 months during 1 year.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 and over.
  • with bronchial cancer treated with immunotherapy,
  • having two assessments of the response to immunotherapy received in day hospitalization with efficiency (stability or partial response)
  • without any graded higher than 1 adverse effects, or uncontrolled grade 1 adverse effects related to immunotherapy
  • eligible for a home-based hospitalization

Exclusion criteria

  • Patient receiving immunotherapy via temporary authorization for use,
  • Frail patients requiring a frequent medical assessment thus day hospitalization cares

Treatment and study plan

Primary outcomes

  1. Feasibility of home-based immunotherapy (percentage of patients who interrupted their home hospitalization for reasons directly linked to that management)

    Time frame: 1 year

    Feasibility under good conditions of home-based immunotherapy, defined by the percentage of patients who interrupted their home hospitalization for reasons directly linked to that management.

Secondary outcomes

  1. adverse effects

    Time frame: 1 year

    Immunotherapy related adverse effects monitoring criteria evaluation

  2. Number of Incidents occurring during the Hospital at Home program handling process

    Time frame: 1 year

    The occurrence of possible incidents related to the Hospital at Home program will be collected at each home based hospitalization.

  3. Quality of Life Questionnaire (EORTC QLQ-C30) total score

    Time frame: at inclusion, month 3, 6 9 and 12

    To study the patient's reported quality of life before and throughout therapy. Quality of life score obtained through self-administered EORCT QLQ-C30 questionnaire at inclusion, month 3, 6 9 and 12.

  4. Patients' Satisfaction Questionnaire

    Time frame: 1 year

    Patients' satisfaction with their home base management will be assessed with a questionnaire. It will be collected at month 3, 6 9 and 12.

Sponsors and collaborators

Lead sponsor

RENAULT Patrick Aldo

Other

Registry information

Official study title

Feasibility of Immunotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting - ImHADom

Acronym: ImHADom

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 26, 2018
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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